Dutch Cangrelor Registry

July 27, 2020 updated by: A.H. Tavenier, Isala
Cangrelor is a fast and directly acting platelet aggregation inhibitor. It is potentially indicated for several types of patients who are undergoing PCI. A nationwide cangrelor registry has up until now not been performed and with the introduction of cangrelor in the Netherlands its efficacy and safety will be determined.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Overijssel
      • Zwolle, Overijssel, Netherlands, 8025AB
        • R.S. Hermanides

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 110 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing (primary) PCI

Description

Inclusion Criteria:

  • Age ≥18 years
  • One of the following criteria:
  • Patients naïve for P2Y12 inhibition undergoing PCI
  • Patients with suboptimal P2Y12 inhibition undergoing PCI (patients who vomited after P2Y12 loading, out of hospital cardiac arrest (OHCA) patients with restoration of spontaneous circulation (ROSC), patients loaded with P2Y12 inhibitors though platelet inhibition still insufficient (<2 hours after oral loading dose)
  • (N)STEMI patients loaded with P2Y12 inhibitors with large thrombus burden (thrombus grade 4 or 5) on initial coronary angiography (CAG) and undergoing primary PCI with expected insufficient P2Y12 inhibition

Exclusion Criteria:

  • Patients on current/chronic treatment with P2Y12 inhibitors
  • Patients (pre) treated with a GPI
  • Patients with recent major bleeding complications or contraindication to dual antiplatelet therapy:
  • hypersensitivity or allergy to and known contra-indication for aspirin, clopidogrel, ticagrelor or cangrelor
  • history of major clinical bleeding or known coagulopathy
  • active bleeding
  • history of intracerebral mass, aneurysm, arteriovenous malformation, or hemorrhagic stroke
  • known severe liver dysfunction
  • Patients that received any organ transplant or are on a waiting list for any organ transplant
  • Patients undergoing dialysis
  • Pregnant or lactating female
  • Patients currently participating in another investigational drug or device study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
NACE
Time Frame: 48 hours
The primary efficacy and safety endpoint is 48 hours Net Adverse Clinical Events (NACE), which is a composite endpoint of all-cause death (including cardiac death), recurrent myocardial infarction, target vessel revascularization, stroke, definite or probable stent thrombosis and bleeding (BARC type 2-5).
48 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
NACE 30 days
Time Frame: 30 days
Net Adverse Clinical Events (NACE), which is a composite endpoint of all-cause death (including cardiac death), recurrent myocardial infarction, target vessel revascularization, stroke, definite or probable stent thrombosis and bleeding (BARC type 2-5).
30 days
All individual endpoints in-hospital
Time Frame: In-hospital, mostly up to 72 hours.
All individual endpoints in-hospital
In-hospital, mostly up to 72 hours.
All individual endpoints at 30-days
Time Frame: 30 days
All individual endpoints at 30-days
30 days
TIMI 3 flow post PCI based on angiographic results
Time Frame: post-PCI, mostly up to 1 hour
TIMI 3 flow post PCI
post-PCI, mostly up to 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Isala

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 17, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 24, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 24, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 17, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 24, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 28, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Dutch Cangelor registry

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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